NCT03910179

Brief Summary

This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

April 4, 2019

Last Update Submit

March 23, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction

    Dynamic arterial elastance (Eadyn) will be recorded at baseline before induction of general anesthesia. Mean arterial pressure (MAP) will be recorded at baseline and continuously until tracheal intubation. The lowest value of MAP will be considered to define hypotension occurrence.

    From baseline (before general anesthesia induction) up to 30 minutes.

Secondary Outcomes (1)

  • Correlation between Eadyn and severity of hypotension due to anesthesia induction

    From baseline (before general anesthesia induction) up to 30 minutes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergone to general anesthesia for surgery that need mini-invasive cardiac output monitoring.

You may qualify if:

  • Patients that will be undergone to general anesthesia for surgery
  • Patients that need mini-invasive cardiac output monitoring during surgery

You may not qualify if:

  • Age \<18 yo
  • Pregnancy
  • Arrhythmia
  • Severe valvular diseases
  • Uncorrectable alterations of arterial signal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, Italy

RECRUITING

Study Officials

  • Abele Donati, MD, PhD

    Università Politecnica delle Marche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 10, 2019

Study Start

September 10, 2019

Primary Completion

July 1, 2020

Study Completion

April 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

IT(1)